For hypercholesterolemia. BLA 761427, held by Lib Therapeutics, Inc.. Lerodalcibep-Liga.
As of Nov 14, 2026, BLA 761427 (Lerochol), held by Lib Therapeutics, Inc., was first approved by FDA on Dec 12, 2025, with 1 approved supplement and 1 published complete response letter.
LEROCHOL TM is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). LEROCHOL is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 12, 2025 | Lerochol (lerodalcibep-liga)Clinical | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lerochol300MG/1.2ML · injectable;injection | Lerodalcibep-Liga | Rx |
| Aug 18, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Dec 12, 2025 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
